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Bee protection in the authorization procedure for plant protection products

Plant protection products are subject to an extensive authorization process, in which the protection of bees also plays an important role. The legal basis is Regulation (EC) No 1107/2009 and its corresponding implementing regulations. In accordance with the criteria stipulated therein, a plant protection product may only be authorized if an appropriate risk assessment results in the conclusion that, under conditions of use in the field, no unacceptable effects will occur on honeybee larvae, honeybee behaviour and the survival and development of honey bee populations.

The Federal Office of Consumer Protection and Food Safety (BVL) is the responsible authority for authorization of plant protection products in Germany. The Julius Kühn-Institute (JKI) is the responsible authority for evaluation of effects of plant protection on honey bees during the authorization process. On the basis of the scientific assessment of the JKI, the BVL decides upon the authorization and on risk mitigation measures related to bee protection, e.g. on directions for use and labelling requirements. The competent authorities in the German federal states are in charge of monitoring the restrictions and where appropriate sanctioning of infringements. If unexpected effects occur, the BVL may amend or, if necessary, withdraw or suspend authorizations, as it was done in 2008 for plant protection products used for seed treatment of maize, which contain active substances from the chemical group of neonicotinoids.

Tests for effects on honeybees

In the EU-harmonized data requirements it is stipulated which tests on bees an applicant has to submit. Regulations (EU) No 544/2011 and (EU) No 545/2011 are the current legal basis; they will be replaced by 2015 by Regulations (EU) No 283/2013 and (EU) No 284/2013. Tests with honey bees are performed in up to three tiers (laboratory, semi-field and field). The scientific method to be used is also specified. Standard tests are performed according to EPPO-guidelines 170 and OECD-guidelines 213 and 214. Further tests with additional methods are required on an individual basis for evaluation under special circumstances, e.g. tests according to OECD guideline 237 or OECD guideline 75 on effects on bee larvae.

Laboratory testing

The test program starts with a laboratory test to determine the acute toxicity of active substances or preparations via oral ingestion and contact. For these two routes of exposure an LD50 is determined. The LD50 is the dose that is lethally toxic for 50 % of the test animals; it is a measure to allow for comparison of the toxicity of different preparations and also allows to decide on whether to continue the tests in semi-field (flight cages), or in the field. For this purpose, the determined LD50 values, as a measure of toxicity, are related to the maximum application rate for the use of the preparation in the field, as a measure of exposure:

Hazard quotient (HQ ) = maximum application rate [g/ha] / LD50 [µg/bee]

The threshold for the hazard quotient (HQ) has been internationally set to a value of 50 after a review of the effects of 82 pesticides. If the HQ for oral and contact toxicity is lower than 50, the tested preparation can be classified as non-toxic to bees, on the basis of the existing data and if the preparation is applied according to label instructions, i.e. unacceptable acute or chronic effects on the survival and development of the colony can be excluded.

Honey bees in a laboratory test to determine the lethal dose Honey bees in a laboratory test to determine the lethal dose © LAVES, Institute for Apiculture Celle

Semi-field and field testing

If the threshold is exceeded, the preparation must be tested additionally under semi-field conditions and if necessary also in the field under more realistic conditions. For certain plant protection products, e.g. systemic insecticides for seed treatment, these higher tier tests are always required irrespective of the hazard quotient. In the semi-field and field test, the following test parameters are determined under practical conditions of use:

  • Dead bees in front of the colonies and in the field
  • Foraging intensity before and after treatment
  • Behavior of bees
  • Development of brood
  • Development of colonies

In field tests, the monitoring continues until at least 4 weeks after the treatment, in the case of systemic insecticides for seed treatment the monitoring continues for several years.

Tunnel test (semi-field ) to determine the impact on bees under practical conditionsTunnel test (semi-field ) to determine the impact on bees under practical conditions © LAVES, Institute for Apiculture Celle

Other tests

For substances that interfere with the development of insects, an additional larval feeding experiment has to be performed, where whole colonies are fed with a sugar solution to which the respective plant protection product is added (method aftrer Oomen et al. 1992). Alternatively, effects on the bee brood have to be tested under realistic exposure conditions following OECD guideline 75. If this test shows impaired development, the test must be continued under realistic field conditions.

An in vitro larval test to determine the toxicity of plant protection products for bee larvae has been published in 2013 by the OECD as test guideline 237.

Bee larvae test to determine the lethal dose in the laboratoryBee larvae test to determine the lethal dose in the laboratory © LAVES Institute for Apiculture Celle

Evaluation

In the evaluation of a plant protection product, all results from tests on bees are used, as well as all other relevant data and information. The risk does not depend only on the properties of the active substances or the plant protection product, but also on the intended use (field of use, application time, application method, application rate). Authorizations are granted only for applications which are safe to bees. If necessary, the BVL can set labelling requirements or directions for use, or e.g. limit the application period. If safe use cannot be achieved by such management provisions, the plant protection product is not authorized.

Labelling and directions for use

Standard classification

All authorized plant protection products are classified according to their hazard for bees. Depending on the classification, they have to be labelled with one of the following texts:

  • The product is classified as hazardous to bees (B1). It must not be used on plants which are in flower or which are visited by bees; this also applies to weeds. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.
  • The product is classified as hazardous to bees except when applied after the end of the daily bee flight until 11 p.m. on the crop to be treated (B2). At all other times, it may not be used on plants which are in flower or which are visited by bees; this also applies to weeds. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.
  • Due to the manner in which authorisation governs application of the product, bees are not endangered.(B3)
  • The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4)

The Bee Protection Ordinance regulates in detail the application of plant protection products which are hazardous to bees.

Tank mixtures

Tank mixtures of pyrethroids which are safe for bees with certain fungicides may be more dangerous to bees than if these products are applied separately with a certain time lag. This is why the BVL generally prescribes one of the two safety instructions below for these products:

  • The product must not be used in combination with fungicides from the group of ergosterol-biosynthesis-blockers on plants which are in flower or which are visited by bees. Mixtures with ergosterol-biosynthesis-blockers must be applied in such a way that plants which are in flower are not treated. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.
  • In combination with fungicides from the group of ergosterol-biosynthesis-blockers, the product may only be used in the evening after the end of the daily bee flight until 11 pm on plants which are in flower or which are visited by bees. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.

Seeds and granular formulations

The serious bee poisonings of 2008 which were caused by maize seeds treated with neonicotinoids and which carried a very high proportion of contaminated dust, together with the sowing technique used (single grain vacuum seeders), resulted in further application restrictions and regulations as precautionary measures, If necessary, the following directions for use and labelling requirements are set with the authorization:

  • It is to be assured with an appropriate dip process, which includes the use of an appropriate adhesive agent, that the treated seed is dust-free and abrasion-resistant.
  • The seed treatment has to be performed with an appliance which is classified as seed treatment device in the list of plant protection equipment (Annex to the 27th notice about the inscription of plant protection equipment into the list of plant protection equipment by the first of July 1993, German Federal Gazette p. 7567, current version).

Both measures ensure maximum adhesion of the respective seed treatment pesticide on seeds.

For plant protection used for seed treatment and for granular formulations, further restrictions can be prescribed:

  • The application of the treated seed should not be done with pneumatic sewing devices (vacuum seeders), unless the construction deflects the dust into the ground.
  • Do not sew treated seeds at wind speeds of more than 5 m/s.
  • The treated seeds including any dust they contain, or dust which is produced during the sowing process, has to be incorporated completely into the soil.
  • The farm manager is obligated to notify the area designated for the sowing of the treated seeds to beekeepers, whose bee hives are located within a radius of 60 m to the sowing area, at least 48 hours prior to sowing.
  • The farm manager is obligated to notify the area designated for the application of the product to beekeepers, whose bee hives are located within a radius of 60 m to the treated area, at least 48 hours prior to application.

These first three instructions are intended to prevent the drift of technically unavoidable residual dust into adjacent areas; the last two instructions should reduce the risk of an uptake of guttation water from treated crops by bees.

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